Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

refractory diffuse non tractional DME.
Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.

Exclusion criteria

Previous vitrectomy, recent cataract surgery less than 6 months,
evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
glaucoma and one eyed patients.

Treatment and study plan

Sub-macular injection of Ranibizumab

Procedure

In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Primary outcomes

The primary endpoint for this study was the change in CMT at the final visit.

Time frame: at the 6 month follow up visit

Central macular thickness

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Jun 5, 2019
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed